Investigating the effects of Empagliflozin on heart function after unexplained strokes
EMPA-ESUS. a Randomised Control Trial to Investigate the Impact of Empagliflozin on Left Atrial Function in Patients with Embolic Stroke of Undetermined Source
This study is testing if the medication Empagliflozin can help improve heart function and prevent future strokes in people who have had unexplained strokes.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of East Anglia Academic / other |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT06715449 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of Empagliflozin, a Sodium Glucose Cotransporter 2 (SGLT2) inhibitor, on left atrial function in patients who have experienced an embolic stroke of undetermined source. The study will involve patients who have been referred for an implantable loop recorder to monitor potential atrial dysrhythmias. By assessing changes in atrial strain, the trial seeks to determine if Empagliflozin can prevent the development of atrial fibrillation, thereby reducing the risk of future strokes. The study is designed as a randomized control trial and will include both Phase 2 and Phase 3 evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have suffered an embolic stroke of undetermined source and are being evaluated for potential atrial dysrhythmia.
Not a fit: Patients with pre-existing atrial fibrillation or flutter, or those with a known cardioembolic source will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment for patients at risk of developing atrial fibrillation after an unexplained stroke.
How similar studies have performed: While other studies have explored atrial function in similar contexts, the specific use of SGLT2 inhibitors for this purpose is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years * Patient has had an embolic stroke of undetermined source, defined as: * Ischaemic stroke or transient ischaemic attack diagnosed clinically + supporting radiological features on CT or MRI imaging * No clinically significant extracranial or intracranial atherosclerosis found on neck imaging * No evidence of prevalent cardioembolic source of embolism - atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumours, mitral stenosis, recent MI, LVEF\<35%, valvular vegetations, or infective endocarditis AND * No other specific stroke aetiology identified (pro-thrombotic states, arteritis, dissection, drug abuse) * Patient has been referred for an implantable loop recorder implant to investigate possible atrial dysrhythmia * Ability to give written, informed consent Exclusion Criteria: * Prevalent atrial fibrillation or atrial flutter * Subsequent demonstration of a cardio-emoblic source * Pre-existent indication for SGLT2i including heart failure with a reduced ejection fraction and Type 1 or Type 2 diabetes mellitus * Contraindication to the commencement of SGLT2i including a history of, or risk factors for diabetic ketoacidosis, such as restricted food intake or a history of alcohol abuse * Hypersensitivity to the active substance or to any of the excipients of empagliflozin * Presence of alternate implantable cardiac devices such as a pacemaker or defibrillator, that would make ILR utilisation redundant * Any condition that may confound the results or interfere with participation such as dementia * An unwillingness to participate
Where this trial is running
Cambridge, Cambridgeshire
- Addenbrookes Hospital — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Vassilios S Vassiliou, PhD
- Email: V.Vassiliou@uea.ac.uk
- Phone: 01603592534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.